Off Label. On the Books.

01/12/2009 08:51 PM |

The FDA has finalized guidelines that govern off-label information sharing.

The FDA document states that doctors should be made aware of experimental uses for drugs and devices -- even if regulators have not approved them.

"The public health may be advanced by healthcare professionals' receipt of medical journal articles ... on unapproved new uses," the agency states. Such uses may even "constitute a medically recognized standard of care," according to the agency.

Knowledge is power.  And information saves lives.

Bravo!
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Sugar and Spice & Everything ... NICE?

01/12/2009 02:09 PM |

National healthcare spending hit a record high of $2.2 trillion in 2007, according to a report just released by the government. The total accounts for over 16 percent of the nation's GDP, and averages out to a $7,421 bill for each one of us.

These numbers are staggering. President-elect Barack Obama and his Secretary of Health and Human Services nominee, Tom Daschle, need to take immediate steps to make sure the money we spend delivers the healthcare we need.

Unfortunately, many of the incoming administration's reform proposals, although well-intentioned, boil down to a single, destructive policy: Price controls.

Perhaps the most damaging healthcare reform we are likely to see in the coming years is Secretary Daschle's plan for a Federal Health Board. Based loosely on Great Britain's National Institute for Health and Clinical Excellence (NICE), this new body would evaluate the effectiveness of different medical treatments with the aim of removing waste from the healthcare system.

Daschle has said that the agency will "reduce or deny payment for new drugs and procedures that aren't as effective as current ones." In the past, however, agencies like NICE have unfairly denied treatment to patients by applying a broad definition of "effective."

Have a look at this new op-ed from the pages of the Washington Examiner … and think hard about what we really want American healthcare to look like.

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R&D and T

01/12/2009 01:41 PM |

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All the News that Fits My Thesis

01/10/2009 04:27 PM |

The flip side of Wall Street Journal reporter Alicia Mundy’s well-documented and often demonstrated disdain for the FDA (and Janet Woodcock in particular) is her affinity for Sid Wolfe.  She writes, “The pharmaceutical industry has a recurring nightmare: Drug-safety crusader Sidney Wolfe becomes a player at the Food and Drug Administration.” (“A Wolfe in Regulator's Clothing: Drug Industry Critic Joins the FDA,” Wall Street Journal, January 9, 2009.)

She is specifically referring to Dr. Wolfe’s appointment as a member of the FDA’s Drug Safety & Risk Management Advisory Committee.  (His term officially began on August 8th of last year and runs through May 2012.)

The article continues, “Dr. Wolfe also has a nightmare: One of his children goes to work for a drug maker. Of the two, the doctor is sleeping more soundly.”

Well, I was interviewed for this article – and I sleep like a baby.

And while my interview wasn’t included in her story, she did mention drugwonks.com and quotes from one of my postings:

“Dr. Wolfe's critics say his judgments are just as one-sided as those he likes to blast. A pro-industry blog, Drugwonks.com, calls him the "general secretary of junk science," citing his group's call for a strong "black box" warning about blindness as a possible result of taking erectile-dysfunction drugs. Drugwonks says that is too rare a side effect for a black box.”

That posting, “The Vision Thing,” appeared on October 24, 2005 and reads as follows:

“Sidney Wolfe, Public Citizen’s General Secretary of Junk Science has just filed a Citizen’s Petition with the FDA calling for a Black Box warning on ED medications because of 48 events of NAION (non-arteritic ischemic optic neuropathy, a loss of vision that is frequently irreversible). To put this in perspective (something Public Citizen really prefers not to do), during that same period 89 million prescriptions were written just for the little blue pill. In July, FDA advised patients to stop taking the pills and call a doctor if they experience sudden or decreased vision loss in one or both eyes — and to tell their doctor if they have ever suffered an episode of sudden vision loss, because such patients are at increased risk of a second episode. A prudent move. But that’s not enough for Dr. Wolfe who says that, the FDA has once again failed in this responsibility. These drugs need much stronger warnings, especially a black box warning such as the one we have proposed. Suggesting that Sidney have his eyes examined would only be a partial diagnosis.”

During my more recent interview with Alicia, I told her my opinion was that Dr. Wolfe’s appointment was a good thing – that, when it comes to FDA advisory committees, all opinions deserve to be heard.

But I guess that, once again, it’s an “all the news that fits my thesis” situation.

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Mundy Morning Quarterback

01/09/2009 04:04 PM |

Alicia Mundy’s story, “FDA Outlays for Morale-Boosting Draw Fire From Lawmakers” (Wall Street Journal, January 8, 2009) is slanted and sloppy journalism.  Aside from the petty attack on Dr. Janet Woodcock (the globally respected CDER director), Ms. Mundy failed to accurately report her story.  It’s not the first case in respect to either issue.

First some background.

In October of 2007, the FDA announced the award of a two-year, $1.5 million contract to the Center for Professional Development (CPD) to assist with the transformation of FDA's Center for Drug Evaluation and Research (CDER), with a particular focus on steps to improve workplace leadership, empower staff, and establish more effective business practices.

The contract was part of the FDA’s ongoing response to a report issued in 2006 by the Institute of Medicine (IOM). Under the contract, CPD will help in the development of practical strategies, including training, tools, and processes that will strengthen CDER’s organizational effectiveness and reaffirm its mission of advancing and protecting the public health.

(The IOM report, “The Future of Drug Safety — Promoting and Protecting the Health of the Public,” identified workplace culture issues in CDER and recommended participation of external management consultants to develop a comprehensive strategy to address them.)

According to the FDA’s own press release (issued in October 4, 2007) “Over the past year, CDER carefully evaluated options and developed a scope of work to solicit the best outside experts to assist in transforming the workplace environment. The entire workforce of about 2,300 in CDER will be included in the workplace transformation effort. CPD will work with CDER’s senior management team and a cross-sectional working group of CDER employees to assess the center’s organizational culture, identify characteristics and a vision for CDER’s desired culture, and develop a plan for implementation and follow-up.”

There was no media coverage and no comment from any member of Congress.

Then, in December of 2008, 14 months after the FDA press release, two members of the House Energy and Commerce Committee Representatives John Shimkus (R, IL) and Joe Barton (R, TX), sent a letter to FDA Commissioner von Eschenbach demanding to know what was going on. Shimkus and Barton wrote, "We are very concerned about the lack of any justifiable metrics for measuring contract success.”

Which brings us to Ms. Mundy’s article in the Wall Street Journal.  Here’s how she began her story, “At a recent retreat for Food and Drug Administration employees, a slide show likened the agency's top drug regulator, Janet Woodcock, to "visionary leaders" such as Golda Meir and Gandhi.”

Mundy quotes Representative Shimkus; “To remove managers for two days to discuss this morale problem, instead of putting food and drug safety first, is ridiculous.”

(It should be noted that Representative Shimkus had no comment about the IOM report when it was released, or about the FDA’s October 2007 press release.  Why did it take him 14 months to break a sweat? This is particularly surprising since his legislative director at the time, Maureen “Mo” Zilly, worked closely with the House Energy and Commerce Committee on FDA issues. Ms. Zilly has since left the employ of Mr. Shimkus to become a lobbyist for Varian Medical Systems as director of federal affairs.)

Mundy also finds space for a quote from Representative Barton, "It's a cinch that if I spent a nickel of taxpayers' money to rank myself with [Sam] Houston and [Stephen F.] Austin, I'd have some explaining to do after the laughter died down."

(Fortunately it is unlikely that Mr. Barton will find himself in that situation.)

What Ms. Mundy did not find room for was the rather lengthy interview she did with Dr. John Jenkins, the FDA’s well-respected director of the Office of New Drugs. His quotes were restricted to defending the “Gandhi” slide and the FDA’s decision to work with a company that also has pharmaceutical industry clients ("I think it's quite silly to bring that up as a point.”)

Why truncate what Dr. Jenkins had to say?  Could it be because he had things to say that didn’t fit into Ms. Mundy’s well-known and well-demonstrated anti-Woodcock, anti-FDA agenda?

As it turns out, that’s exactly the case. Here are all of the questions and answers (taken from a verbatim transcript of Ms. Mundy’s complete interview with Dr. Jenkins) that present a much more balanced and insightful view of the situation under discussion.  It also shows just how “selective reporting” can miss the real story.

DR. JOHN JENKINS:  Hi, Alicia.  How are you?

ALICIA:  I’m fine.  I’m sorry to trouble you.  I’m doing a story on the workplace culture and communications contract.

DR. JENKINS:  Okay.

ALICIA: I wanted to get your view based on what I’ve seen of your slides on what you think the workplace culture is right now?  Do you think the morale is that low?  Do you think there is, you know, you seem to be addressing the issues – is it that bad or does the FDA just attract a lot of criticism, you know?  Are there really this many serious concerns about science versus popularity and drug approval?  Or is that, you know, is that something that’s been kind of blown out of proportion?  And that seems to be part of what your – the slides that I saw on equal voice or your part of equal voice were getting at, and that’s basically what I wanted to ask you about.

DR. JENKINS:  My presentation at the summit was about a process improvement effort that we’ve had ongoing in the Center now for about four years about how to further improve the way we do our review work to ensure that we’re making certain that all the disciplines involved in the review of applications are engaged, they’re part of the team and they’re heard and that their voices are heard.

So the effort we had underway for the review process improvement team pre-dated any of the cultural contract work and as the slides in my presentation note, they overlap and are essentially the same concept. 

We want to have a review process where everyone is bringing their scientific input to the table, they’re sharing their perspectives, they’re a member of the review team, their voice is heard.  They get feedback on their recommendations and opinions and in situations where their recommendations and opinions are not the direction that the decision makers on the application feel is appropriate, they get that feedback and know why their recommendations are not the ones that are carrying the decision making process.

So the review process, the 21^st century review process that I talked about in my presentation is, I think, a real day-to-day manifestation of the cultural values of equal voice that we’re trying to ensure that everyone understands across the entire Center. 

One of the comments I made at my presentation that I make it frequently internally in discussions with staff is that consensus is not our goal when we’re reviewing an application, and that takes some people by surprise because most of the time, we actually do reach consensus, but it can’t be the goal because if consensus is the goal, I think, it places a subtle pressure onto any member of the team who might have a differing viewpoint to conform to the majority view and actually our decisions are the strongest when we hear all those dissenting views and they’re discussed among the team and the decision maker, explains why they agree with one position and they don’t agree with another.

So while consensus is often the outcome, consensus is not the goal in our review process and I think my presentation at the summit was to show that this whole concept of equal voice was not something new, it’s something that has been part of our process for many years and we’re taking it to the next level to make sure that it’s really understood clearly by all members of the Center and all members of the management team.

ALICIA:  What do you mean by taking it to the next level?

DR. JENKINS:  Well, we’re trying to make sure that everyone in the Center understands the concepts of equal voice, what their role is in the review process.  One of the important concepts of equal voice is about it relates to the discipline, not the individual because we need to hear from a particular discipline about their recommendations for an action on application and there’s a process within that discipline for any differences of opinion among the reviewers and the managers to be resolved.

So we’re trying to make very clear that this is the culture that we expect to operate within the Center, you know, going back to the IOM report on drug safety, one of their recommendations that we undertake this type of an effort to reiterate these issues.  I think they’ve always occurred and the vast majority of the interactions internally within the Center.  This is our attempt to try to ensure that they occur with all interactions on review issues within the Center.

ALICIA:  I don’t mean to necessarily go down this path, but since this was the focus of your presentation, you know, I know you’re saying that this goes back four years, but the IOM report, you know, they came to a pretty strong conclusion, I guess, that if this process has been underway at the Agency, it didn’t seem to be producing much because they were very critical of CDER’s review process and I think they called it at one point an obstacle to the FDA.

So they hadn’t – when I looked through the report, they didn’t seem to focus on an ongoing process or, you know, an earlier process to try and make sure that there were equal voices getting, you know, getting heard.

DR. JENKINS:  I don’t think you’re understanding the distinction between the program that we’ve had underway for several years to deal with improvements and how we manage the review of applications, which is the 21^st century review process that I discussed at the summit and the work has been in progress now for several years, from the IOM report which was heavily focused on post-marketing safety issues.  The 21^st century review process is primarily focused on pre-approval review of applications.  The IOM report was much more heavily focused on addressing post-approval safety issues, but they all dovetail together in the concept that I described earlier that we want to make sure that every voice is heard, every voice is respected.  It doesn’t mean that every voice carries the day on what the decision will be, but we want to make sure that we have a culture where people feel free to express their opinion and support it with scientific data and the ability to justify how they reach that conclusion.

So I think there are parallel issues, but they overlap significantly.  I don’t think the IOM report had much, if anything, to do with review process improvement efforts that I am describing.

ALICIA:  Well, I don’t think it had to do with the review process improvement efforts, but I think there are definitely parts of it that had to do with the new drug approval process in general and, again, concern that science, you know, does not always – science is not always the deciding factor and decision making.

DR. JENKINS:  My take on the IOM report was that they were interested in ensuring that all the perspectives were being incorporated in the decision making and that’s exactly what we’re doing through reiterating the equal voices principles that, you know, ultimately, there has to be someone who makes a decision in a regulatory organization.  We are not a democracy internally in how we can reach a decision making process.  Someone is charged and responsible with making hundreds, if not thousands of regulatory decisions each week, month and year.  We want to make sure that those decisions are informed by all the perspectives and all the data and all the viewpoints, but it doesn’t mean that each individual viewpoint will always be the one that leads to the Agency action.

As I said earlier, we think that our actions are the strongest when they’ve been informed by all those different perspectives, and that’s what equal voice is about.  It’s what the 21^st century review process is emphasizing about teamwork and mutual accountability of the members of the team, sharing information, speaking openly, being able to defend your scientific position and not simply state an opinion, but not be able to support it.

That’s my perspective on what we’re trying to achieve, and I think we’re very much in line with trying to achieve the goals that the IOM report set out for us.

ALICIA:  When I look through the slides, there were a lot of, in general, from the conference.  I didn’t see any, what didn’t – a presentation by anyone who might have, not necessarily taken issue with your perspective, but who might have raised the idea that there were times when significant and serious difference of opinions were – it’s not just that they weren’t included in the final decision making, but were actively suppressed and I didn’t see that necessarily addressed in any of the slides or anything that would have, you know, spoken to your issues. 

Is there anything here that I’m missing?

DR. JENKINS:  Well, I don’t know what the packets of slides you have available to you are, but the presentations were designed to lay out the goals of the meeting and the concepts that we were trying to achieve and some examples and some case studies. 

There was plenty of opportunity during the two days of the meeting for discussion and dialogue to occur and opportunities for the 475 or so people who were there who were all managers within the Center to raise any concerns that they might have about whether these principles have always been applied or will they always be applied in the future.

So I think there was plenty of opportunity for that discussion to occur.  There was a lot of discussion amongst the tables where people were seated.  There was a lot of time spent having them interact with one another.  They were purposely seated in a way that we maximized the mixture of the staff so that they weren’t just people who normally would sit together.  They were a cross-section of the Center at each table.

So I think there was plenty of time for discussion about any concerns people might have about, you know, these principles and how they might be applied. 

ALICIA:  Okay.  One thing that I wanted to ask, well, actually, after your presentation, you know, I don’t want to put you in an awkward situation.

DR. JENKINS:  Reaction exactly to what, again?

ALICIA:  There was a slide, it was visionary leaders and as I’ve seen it and as it has been explained to me by five or six participants, basically, you know, it seemed to suggest that Dr. Woodcock is in with – vision is on the same plane with Gandhi’s or Barack Obama’s or Margaret Thatcher’s or Golda Meir’s as a visionary leader and, you know, there were a number of people who called me, I guess, within a couple of days after the conference to express a little bit of shock about that and that’s why I had requested to find out the context of that slide and what, you know, I guess what FDA officials think of it.

DR. JENKINS:  Well, my take on the slide was that, in part, it was there to inject some humor into the proceedings and as I recall at the meeting when the slide came up, there was laughter in the room because there was some humor associated with that. 

The talk – when that slide was used was one where it was talking about leadership and leading through a change process and that’s what we’re trying to do as the senior management team of the Center is lead through a change process and it was an example of thinking about visionary leaders and how they went about accomplishing their goals.

Now, I don’t think anyone was trying to imply that Dr. Woodcock is on the same level of world leader as Gandhi or Barack Obama.  They were pointing out that within the context of the job that she is responsible for doing; many people view her as being a visionary leader.  And so I think people pointing that out as an issue for a two day conference that was focused on trying to improve the culture of the Center and how we work together in equal voice, to my mind, is really a distraction from the important issues that occurred over two days.

Dr. Woodcock is the one who had the vision to bring this meeting together.  We took two days away from very busy schedules for 475 managers from across the Center to come together and it emphasized how important she and the senior management team for the Center view this effort.  It’s in direct response to what was recommended by the IOM report.

So I really think it’s a distraction for someone to focus on that one slide, which I think was intended to inject a little humor into the proceedings, but was also there to make a point that everyone within their capacity at their job can be a visionary leader.

So it was not to suggest that Dr. Woodcock is on the same plain of a visionary leader as a world leader like Gandhi, but I think was making the point that every one of us in our job can be a visionary leader to effect change.

ALICIA:  Okay. I’m just curious, you know, were your slides put together by the company or did you do your slides?

DR. JENKINS:  Well, I think it’s important to look back at the preparation for the two day summit in general.  The contractor, CPD, was an important partner in helping us put together this program and supporting, preparing for the program.  There was a steering committee within the Center of senior managers within the Center that worked very closely with the contractor to develop the agenda, the plan for the meeting, the logistics, et cetera, as part of the process for developing the meeting, the steering committee working with the senior management team of the Center developed the agenda presentations and then working with the contractor, we developed the slides that would support those presentations.

So in the case of my slides that I used, the initial draft of the slides was prepared by the contractor based on the discussions that they had had with the steering committee and discussions that the contractor had had with me about what I thought we should cover.  The contractor shared the draft of the slides with me and we had several meetings over the course of several weeks where we had adjusted slides, I edited the messages, et cetera.

So at the end of the day while I did not physically generate the slides, the message that was on the slide and the content on the slides were mine. 

            ALICIA:  Okay.  All right. 

            DR. JENKINS:  I admit very readily that some of the graphics that were on the slide, I’m not capable of producing in a PowerPoint program.

            ALICIA:  And a graphic artist –

            DR. JENKINS:  I was very happy to have a contractor who could generate those concentric circles and other flow charts and the diagrams because I can’t do that.

            ALICIA:  I’ll tell you, some of them were impressive.  Some of them were definitely state-of-the-art PowerPoint stuff, anyway.

            You know, I guess the big issue is that at least for some veteran FDA employees, they feel that there has not been that much of a serious, ongoing effort with equal voices and the conference did not, you know, did not get at the key issues of how to get dissenting opinions over science and safety heard versus, you know, a general theme of improving culture with skill workshops on using better choices of language and vocabulary and behavior, which I guess on its face seems like something that people should know anyway.

            DR. JENKINS:  Well, you know, I would disagree strongly with those comments and those assertions.  That’s not the meeting I attended for two days last month and it was not the meeting that was the goal that we put together.  Again, I would point out that we took this issue so seriously that we took 475 people away from their busy jobs off site for a two day meeting to discuss the culture that we want to make sure that everyone understands that we’re trying to achieve in the Center for decision making and how we work together as a group. 

            As part of the meeting, there was a survey done about the value of the meeting to the participants and the majority of the respondents to that survey were favorable.  There were some who were not so favorable, but the vast majority of the people who attended the meeting were favorable. 

            Another component of the cultural contract that I would point to is the contractor helped us do a cultural survey, probably about a year ago to help us get a baseline understanding of what is the culture and the status of that culture in the Center as a snapshot and that survey results were very positive for the most part.  They pointed out areas where we needed to improve and we could do a better job, but the vast majority of the respondents to that survey were very positive about working in CDER, the importance of their work, the value that they felt that they added to the system.

            So I would just very strongly disagree with the people that you have been talking to about the focus of the meeting, the value of the meeting. 

            I saw a lot of people very engaged for two days, two very long days and I saw people at the very end still very engaged, very enthusiastic about the fact that they were getting to meet that they normally don’t get to meet and talk to and to share perspectives.

            So I think it was a very positive meeting.
    

Indeed. An excellent interview with an important FDA official who rarely engages in lengthy conversations with the media.  What possible reason could there have been to waste such an open and honest and timely and relevant interview?

Could it be because it justified the agency’s decision to hold the workshop?  Could it be because it makes Janet Woodcock look like the superstar she is?  Or could it be something else? Inquiring minds want to know.

One thing’s for sure, it is unlikely that anyone will be creating a PowerPoint slide comparing Alicia Mundy to Edward R. Murrow any time soon.

And to quote the great journalist himself, “To be persuasive, we must be believable; to be believable we must be credible; to be credible, we must be truthful.”

Amen.

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Farewell and Lotsa Luck to Pharmalot's Ed in Chief

01/08/2009 11:57 PM |

Drugwonks and www.pharmalot.com butted heads more often than not on many issues.  But we always admired Ed Silverman's writing style and breadth of coverage.  It's the reason his blog became so popular and well read.  Ed is a friend, neighbor and colleague and we look forward to hearing and reading more of his comments in another venue.
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Yes Virginia ...

01/08/2009 01:30 PM |

Behind the Health Spending Data

Spending on health care in the United States grew in 2007 at the lowest rate in nine years, according to government analysts — a sliver of good news for those worried about the relentless rise in health care costs. But buried within the overall statistics was sobering evidence that health costs continue to be a pressing concern that can only be remedied through deep-seated reform in the delivery of health services.

The Centers for Medicare and Medicaid Services reported this week that total health care spending rose 6.1 percent in 2007, slightly less than the growth of 6.7 percent in 2006. Even so, it continued to expand faster than the overall economy, reaching a total of $2.2 trillion in 2007, or 16.2 percent of the gross domestic product, a record.

The chief reason for the overall slowdown was much slower growth in spending on prescription drugs. Retail spending on prescription drugs rose only 4.9 percent in 2007. That was the lowest rate in more than four decades, well below the 8.6 percent growth the previous year and the average of 9.4 percent a year from 2001 to 2006.

Government analysts attributed the deceleration to increased use of generic drugs as many brand-name blockbusters lost patent protection, as well as to slower growth in prescription drug prices and safety concerns that depressed sales of some drugs. The big uncertainty is whether the slowdown will continue or is a temporary phenomenon.

In contrast to prescription drugs, spending for most other health care services, including payments to hospitals, clinics, nursing homes and home health services, grew at about the same rate or faster in 2007 as in 2006. Only the growth rate in spending for physician services declined, partly because Congress reduced Medicare payments to doctors for imaging services that many experts believe are widely overused.

Given that prescription drugs make up a relatively small slice of total spending on health care — some 10 percent — it will be imperative to reduce the growth rates in spending on hospital care, nursing care and other medical services if health care is to become more affordable.

It will be very interesting to see how some politicians, keen to limit access to medicines a la NICE, address restrictions to hospital care and other medical services that represent much larger portions of our national healthcare expense.

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The other SG for SG

01/07/2009 03:16 PM |

Not Sanjay Gupta -- but Rear Admiral Steve Galson.

The former is interesting and unquestionably telegenic -- but the latter is highly qualified and, as it happens, the current Acting Surgeon General and a career United States Public Health Service officer.

Prior to his appointment as Acting Surgeon General, Steve Galson served as the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). As the director, RADM Galson oversaw CDER’s broad national and international programs in pharmaceutical regulation and provided leadership for 2300 physicians, statisticians, chemists, pharmacologists and other scientists, as well as administrators whose work promoted and protected public health by ensuring that safe and effective drugs are available to the American public.

RADM Galson began his Public Health Service career as an epidemiological investigator at the Centers for Disease Control after completing a residency in internal medicine at the Hospitals of the Medical College of Pennsylvania. He has held senior-level positions at the Environmental Protection Agency, the Department of Energy where he was the Chief Medical Officer, and the Department of Health and Human Services.

RADM Galson received his Baccalaureate Degree from Stony Brook University in 1978, an M.D. from the Mt. Sinai School of Medicine in 1983, and a M.P.H. from the Harvard School of Public Health in 1990. He is Board Certified in General Preventive Medicine and Public Health as well as in Occupational Medicine.

RADM Galson is the recipient of numerous PHS awards, the Robert Brutsche Award from the Commissioned Officers Association of the USPHS and the Founders Award from the Association of Military Surgeons of the US. He is also the recipient of three Secretary of Energy Gold Awards.

SG for SG.  And make that Steve Galson.


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Dr. Price is Right

01/07/2009 03:00 PM |

Late last year we interviewed Representative Tom Price (R, GA) on his vision for 21^st century healthcare reform. The full video interview can be found be clicking here and then (in the "Newsmakers" section) on the bespeckled gentleman in shirtsleeves and red tie. Price's opinions are all the more germane since he is both the new chairman of the Republican Study Committee and one of the few MDs serving in Congress.

Here’s what Dr. Price had to say in today’s Wall Street Journal:

The GOP Should Fight Health-Care Rationing: Obama's HMO deserves principled opposition.

Perhaps the greatest missed opportunity of the past eight years was the chance for Republicans to fundamentally reform the terribly broken American health-care system. Access to quality health care has long been a professed priority, yet Republicans have been reluctant to tackle the issue.

As a physician, this is deeply disappointing to me because patient-centered health care is, at its core, conservative. Health care is fundamentally a personal relationship between patients and doctors. To honor this relationship -- consistent with Republican ideals -- our goal should be to provide a system that allows access to affordable, quality health care for all Americans, in a way that ensures medical decisions are made in doctors' offices, not Washington.

Republican unwillingness to address the issue, however, has left us facing an emboldened Democratic Party well equipped to push a government-centered health-care agenda. While Democrats are still dangerously misguided in their policies, this time they are prepared to avoid the political mistakes of the Clinton administration.

For a preview, look no further than "What We Can Do About the Health-Care Crisis," a book published this year by former Sen. Tom Daschle, President-elect Barack Obama's choice for secretary of Health and Human Services. Atop the list of worrisome ideas proposed by Mr. Daschle is the creation of an innocently termed "Federal Health Advisory Board."

This board would offer recommendations to private insurers and create a single standard of care for all public programs, including which procedures doctors may perform, which drugs patients may take, and how many diagnostic machines hospitals really need. As with Medicare, for any care provided outside the board's guidelines, patients and physicians would not be reimbursed.

Mr. Daschle is quick to note the board's standards would serve only as a suggestion to the private market. Yet to ensure that there are no rogue private insurers, he has proposed making the employer tax deduction for providing health insurance dependent on compliance with the board's standards. In an overtly political ruse, Democrats will claim they are dictating nothing to private providers, while whipping noncompliant insurers in place through the tax code.

To be sure, this strategy seeks to eliminate private providers completely. Forced into accepting rigid Washington rules and unsustainable financing mechanisms under Mr. Daschle's plan, most private insurers would be quickly eradicated. Or, as Mr. Daschle soberly predicts in his book, "the health-care industry would have to reconsider its business plan."

If we fail to recognize the scope and scale of Democratic ambition on this issue, we will find ourselves with a permanent Washington bureaucracy prescribing patient care. Our goal, however, must not be confined to defeating a Democratic proposal. Instead, we must advocate for a positive approach to health-care reform that does not sacrifice patient care to achieve its goals. This patient-centered approach must be built upon two pillars: access to coverage for all Americans and coverage that is truly owned by patients.

First, we must fundamentally reform the tax code so that it makes sense for all people to have health insurance. This may be readily accomplished through the adoption of tax equity for the purchase of insurance, active pooling mechanisms for increased purchasing power, and focused use of tax deductions and credits. Through positive changes in the tax code we can make health-care cost effective and create incentives so there is no reason to be uninsured. This way, care is purchased without government interference between you and your doctor.

Secondly, we must transform our health-care model to one that is owned and controlled by patients. Currently, most Americans receive coverage through a third party, leaving health-care decisions to an employer or the government. By creating a new system in which Americans are provided the opportunity to purchase whichever health-coverage product fits their personal needs, insurers would be forced to focus on patients. Not until patients truly own their own health plans will we see the accountability and flexibility needed to ensure quality care and necessary cost-lowering efficiencies.

A historic debate about American health care is ast approaching. We are not doomed to a Washington-run bureaucratic health-care system, so long as Republicans push for the right remedy for health care and return to being the party of solutions.

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Health Hints from the Stars

01/06/2009 08:13 PM |

Looks like Tom Cruise is back in full Scientology form after playing a Nazi officer with a New Jersey accent:

MADRID, Spain - Actor Tom Cruise said Scientology teachings helped him overcome childhood dyslexia, a Spanish magazine reported.

"Cruise was quoted by Spanish magazine XL Semanal as saying he was diagnosed with the learning disability when he was 7 years old.

Cruise said he was often anxious, frustrated and bored as a youth and couldn't concentrate in class, the magazine reported on its Web site Sunday.

The magazine quoted Cruise as saying he was functionally illiterate when he graduated from school in 1980, but learned to read perfectly as an adult through Scientology technology.

XL Semanal said the interview was conducted in Los Angeles, but did not say when. A transcript of Cruise's original comments in English was not available.

The Church of Scientology was established in 1945 by science-fiction writer L. Ron Hubbard, and claims 10 million members around the world. Cruise and fellow actor John Travolta among its more famed followers."

A functional illiterate joins "religion" that believes aliens inhabit our bodies that can cure most brain diseases.

Meanwhile, diet tips from Gwyneth Paltrow.  Do NOT try this at home or on Yom Kippur:

Gwyneth Paltrow: How I'm Losing Those Holiday Pounds

By Us Magazine January 5, 2009In her latest GOOP newsletter, Gwyneth Paltrow reveals how she is hoping to shed some pesky pounds she gained over the holidays.

"I need to lose a few pounds of holiday excess. Anyone else?" she says. "I like to do fasts and detoxes a couple of times during the year, the most hardcore one being the Master Cleanse I did last spring. It was not what you would characterize as pretty. Or easy."

See how Gwyneth Paltrow's style has changed over the years.

So she is not stuck subsisting solely on lemon water this winter, she has asked her doctor, a detox diet specialist, for the guidelines he uses to achieve a good detox that is not as hallucinogenic.

"What it came down to was this: you can detox easily and effectively while you continue to eat as long as you are cutting out the foods and other substances that interfere with the detoxification process," Paltrow writes.

See photos of famous weight winners.

She is cutting out dairy, grains with gluten, meat, shellfish, anything processed (including all soy products), fatty nuts, nightshades (potatoes, tomatoes, peppers and eggplant), condiments, sugar and alcohol, caffeine or soda.

Instead, her diet will consist of salads, fruit smoothies, chicken, soups and lots of water.

Sounds non-hallucinogenic to me.  I am sure the doctor is following the DeTox Doc Society practice guidelines.

 

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In Her Majesty's Service: Cut the QALY

01/06/2009 04:43 PM |

Life is cheap in Britain's NHS, but not cheap enough for Alan Maynard a health economist and Chairman of York Hospital in the UK who was recently bestowed the title Officer of the British Empire (OBE) for his services to the NHS.

Here's Sir Alan's most recent contribution:

Time for NICE to lower its cut-off price?

A leading health economist has suggested that NICE’s new year’s resolutions should include lowering the cut-off threshold for new drugs from £30,000 per quality adjusted life year gained to £20,000.

Professor Alan Maynard’s suggestion comes in the wake of the recent re-announcement of the Government’s response to the Richards Review on drug top-ups, which has suggested that for end-of-life rarer conditions such as cancer, the cut-off threshold should be raised to £70,000 / QALY.

Professor Maynard, whose OBE was announced in the New Year Honours list, also points to findings from a House of Comons Health Select Committee report that the Scottish Medicines Consortium, which reviews new technologies within six months, has reached “remarkably similar conclusions” to those on NICE, and proposes that this duplication is wasteful.

Discriminating against those not near the end of life

Maynard also argues that the £70,000 threshold for people with rarer end-of-life illnesses represents “an arbitrary equity value judgment (which) is inherently unfair for those not in the last two years of life”.

He also emphasises that NICE has much work to do in removing from use existing technologies already adopted in the NHS that are not demonstrably cost-effective. Writing on Health Policy Insight, Maynard suggests that the current recession’s inevitable effect on NHS funding “requires NICE to pay much more attention to marginal technologies already being used in the NHS, as their elimination will free resources to provide better patient care”.

Maynard also suggests that NICE should work “much harder to acquire a price setting role” – a radical proposal, given the existing barrage of negative publicity NICE has faced over its refusals to approve products for NHS use.

Hmm. If 70,000 pounds is arbitrary, then so is 20,000. And so is the judgment that the recession's inevitable effect on NHS should lead NICE to use even older and cheaper technologies and ration new ones further. Sir Alan as a hospital administrator? I'd bring my own food if I had to go inpatient at York Hospital. Come to think of it, what are the mortality rates there?

The fact is, NHS has a 3 million pound surplus attained in the same way NICE and NHS have rationed technologies. At the same time rates of chronic illness are rising and death rates from cancer are the highest in the Western world.

And here in America, comparative effectiveness is being offered as a tool to solving the innovation "problem." In reality, comparative effectiveness is just an arbitrary judgment made by government about who should get what and when.

Read More


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Just What We Need -- Dentzer Healthcare Reporting

01/06/2009 01:57 PM |

No, really.

Susan Dentzer (editor-in-chief of Health Affairs and an on-air analyst on health policy for the NewsHour with Jim Lehrer) has an excellent and timely Perspective piece in the January 1 edition of the New England Journal of Medicine, “Communicating Medical News — Pitfalls of Health Care Journalism.”

Some of her comments include:

“Whether they realize it or not, journalists reporting on health care developments deliver public health messages that can influence the behavior of clinicians and patients. Often these messages are delivered effectively by seasoned reporters who perform thoughtfully even in the face of breaking news and tight deadlines. But all too frequently, what is conveyed about health by many other journalists is wrong or misleading.”

“Consider news reports on the findings of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, reported in March 2006. The STAR*D study was a complicated trial designed to test treatment approaches for seriously depressed patients who weren't helped by taking one antidepressant. The results showed that 50% of patients had improvement after pursuing additional treatment steps, such as switching or adding medications, taking a higher dose, undergoing cognitive therapy, or some combination of these. Arguably, for people with serious long-term depression, this was hopeful news. Yet on March 23, 2006, the Washington Post ran a story whose lead paragraph framed the study as a failure because half the patients had no improvement: ‘Antidepressants fail to cure the symptoms of major depression in half of all patients with the disease even if they receive the best possible care, according to a definitive government study released yesterday.’ Apparently, simply noting that half got better and half did not was not deemed sufficiently new or interesting.”

“But so uncertain and episodic has been past coverage of drug safety and efficacy that much of the news media now feel duty-bound to report on many drug-related findings whether reporters understand them or not. A recent high-profile example was coverage of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial. Although the study in fact raised questions about whether ezetimibe yielded any benefit when added to statin therapy, its findings were almost consistently misreported. Some journalists asserted that it showed the drug had no benefits in preventing heart attacks and strokes — something it certainly did not show, since heart attacks and strokes were not end points in the trial. We will never know the cost of this misinformation in terms of panicked patients or physicians who, perhaps unnecessarily, discontinued use of the drug.”

“In my view, we in the news media have a responsibility to hold ourselves to higher standards if there is any chance that doctors and patients will act on the basis of our reporting. We are not clinicians, but we must be more than carnival barkers; we must be credible health communicators more interested in conveying clear, actionable health information to the public than carrying out our other agendas.”

The full article can be found here. 

Well done and well said Susan.
 

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Adieu Pharmalot

01/05/2009 06:45 PM |

Sad news from the pharma blogosphere -- Pharmalot is ending its two-year run.  We wish Ed Silverman great success and happiness.  His voice and wit and intelligence will be missed.
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What about Kyle and Cartman?

01/05/2009 05:23 PM |

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Hillary TRIPS the Light Fantastic

01/05/2009 12:01 PM |

On December 27th, China passed a new patent law that will allow domestic Chinese pharmaceutical manufacturers to manufacture knock-offs of on-patent medicines – and export them to third countries.  According to Yin Xintian, director the regulations department of China’s State Intellectual Property Office, the new law will “ensure patients can get the drugs they need when they need them.”

It will also be a boon to China’s pharmaceutical manufacturing industry.  Oh well, at least we know that quality won’t be a problem.

The new Chinese law is based on TRIPS – and is the latest example of how international organizations are wrecking havoc with the keystone of medical innovation – intellectual property rights.

It should also serve as a potent reminder that Secretary of State-Designate Hillary Clinton will indeed have an important role in healthcare reform – albeit of an international nature. And the implications for continued U.S. support of intellectual property rights could be profound.

Many in healthcare policy land were pleased that Senator Clinton was tapped by President-Elect Obama to head the State Department because it would (in the words of more than a few) “get her out of the healthcare reform debate.”

Not so fast. 

By moving into the corner office at Foggy Bottom, Mrs. Clinton will be a force majeure in global healthcare issues by dint of her ability to appoint and otherwise influence the United States delegations to the many Geneva-based organizations that address issues such as compulsory licensing (the World Trade Organization) and access to healthcare issues (the World Health Organization).

The U.S. has long been a bulwark in support of global intellectual property rights – and Mrs. Clinton should be questioned about her views on this and related issues during her upcoming Senate confirmation hearing.

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Signal-to-Noise Nuance

01/04/2009 01:12 PM |

By Michael Kahn

LONDON (Reuters) - Many genes linked to various cancers do not appear to raise the risk of getting cancer after all, according to an analysis of hundreds of studies published on Tuesday.

The findings highlight the need to exercise caution over the increasing number of studies associating common genetic variations with a range of diseases, said John Ioannidis of the University of Ioannina School of Medicine in Greece.

"The whole thing about genetic variations and links to diseases like cancer are very exciting, but the general public should be quite cautious about jumping to the conclusion that if they have a change in one gene or another they are doomed," Ioannidis, who led the study, said in a telephone interview.

"Genetic effects are very complex and very subtle and we need to know a lot more before we can make strong recommendations based on genetic profiles."

Ioannidis said his team had looked only at common genetic changes or polymorphisms, not at rare mutations, which in genes such as BRCA1 and BRCA2 significantly raise breast cancer risk. The rare form of these variants, for example, accounts for an estimated 5 to 10 percent of breast cancers.

Since early 2007, variations at more than 100 places on the genome have been linked to diabetes, heart disease and certain cancers.

The problem, researchers say, is that many of these genes typically interact in a complicated manner and their ultimate effects are influenced by the environment -- diet, exercise, smoking and other behavior -- in often poorly understood ways.

Ioannidis and his colleague Paolo Vineis of Imperial College London analyzed hundreds of published studies linking genetic changes to different cancers. They found that, out of 240 associations between a specific mutation and a cancer, only two genes involved in DNA repair and tied to lung cancer -- XRCC1 and ERCC2 -- turned out to be strong candidates for such a link.

"Most of the associations had weak or modest credibility," he said. That included PARP1 for breast cancer and CCND1 for head and neck tumors.

The problem is that on their own, the earlier studies fail to provide a complete picture and run the risk of drawing conclusions from too limited an amount of data, Ioannidis said.

This does not mean studies linking genes to cancer and the risk of other diseases have completely missed the mark, but rather that it takes a mountain of evidence to reach strong conclusions when it comes to the human genome, he added.

"Our study shows that it really takes a lot of research effort and many, many studies to be able to pinpoint a couple of associations," Ioannidis said.

(Reporting by Michael Kahn; editing by Maggie Fox and Tim Pearce)

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Peace In Our Time?

01/02/2009 08:31 PM |

I was in Israel this past summer visiting the National Biotechnology Institute of the Negev (NBIN) which is outside of Beersheva.  The genesis of NBIN was the collection of genetic data from Bedouins as part of a health clinic Ben Gurion University established for that nomadic people.  Now NBIN has a powerful platform for developing genetic markers for diseases, particularly those that afflict the Arab world.    NBIN -- along with school chidren, synagogues, day care centers, hospitals and the very health clinics mentioned above --  is now within the range of rockets being fired by Hamas, rockets acquired during a "cease fire." 

Those who seek to establish a moral equivalence between Israel and it's enemies, particularly journalists, lack both conscience and context. 
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A Post-Nissen World

01/01/2009 05:41 PM |

Steve Nissen believes that drugs should be evaluated strictly in terms of survival ... I guess quality of life means nothing.

See here.

A study published in July showed that diabetics who take insulin plus a diabetes pill have a lower risk of developing Alzheimer's disease than diabetics who take insulin alone.

Oh and that pill?  Avandia or Actos.  How many people are NOT on either thanks to Nissen's cardiovascular fearmongering?
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Personalized Denials?

12/31/2008 03:19 PM |

The Wall Street Journal, reports that,  “Amid studies showing the anti-clotting drug Plavix may not be effective for 30% of cardiac patients, federal regulators are considering updating the drug's label to include data on genetic factors that could interfere with the medicine.”

(Nearly 25 million prescriptions were written in the U.S. in 2007.)

“The issues concerning Plavix show the promise and problems with the new area of "personalized medicine," where drugs are tailored to certain people based on their genetic makeup. In Plavix’s case, the three studies pinpointed a likely genetic factor inhibiting the drug's efficacy -- but that finding has opened up more unanswered questions.”

“Unanswered questions” are a good thing – it means that we’re now being forced to think hard about how to address these new facts.  Nobody said personalized medicine was going to be easy.

Three studies last week -- two in the New England Journal of Medicine and one in the Lancet -- identified a genetic abnormality in some heart patients that could interfere with their liver's ability to completely process Plavix in the bloodstream, but they differed on the number of patients affected.Two of the studies suggested the drug was less effective in about 30% of the population that has the mutated gene from one parent, while one study indicated the drug is less effective in the 5% of the population that has the gene from both parents.

According to Larry Lesko, director of the FDA's office of clinical pharmacology, "What I think we're struggling with is what is the label going to say in light of all the ambiguous data out there."

That’s a key point to remember – that “personalized” labeling is not a black-and-white proposition.  And it’s the FDA’s job to review all of the information (much of it vague and contradictory) and then make the best choice on behalf of the public health.  Larry Lesko’s honesty acknowledges some tough truths about drug regulation – like the nascent nature of the agency’s understanding of pharmacogenomics relative to “safe use” and the dearth of 21st regulatory tools to explore it. 

These new studies mean "life just got very confused and much more complex" for cardiologists and patients, said Dr. James Calvin, director of cardiology at Rush University Medical Center in Chicago. He added, "We have to start to become very, very aware of how big an issue this is."

Indeed, not “safety” per se, but “safe use.”

According to Dr. Lesko, the agency is considering amending the Plavix label to recommend that patients get a genetic test to screen them for the gene mutation.  This is similar in concept to the FDA’s change to the Warfarin label – but with one big difference ... at present there aren't any alternatives to Plavix approved for use in the United States. "Once you know the answer, what do you do?" said Douglas Weaver, president of the American College of Cardiology.

Good question – and one that the FDA should acknowledge and take into consideration as it reviews the various safety profiles of new medicines that could fill this gap.

Dr. Paul Gurbel, who authored one of the first studies showing that many heart patients don't process Plavix effectively, said, "Clearly I think just the blind administration of these drugs is rapidly coming to an end."

Dr. Grubel’s comment is a clarion call that the era of “trial-and-error” medicine is over.  One size does not fit all.  Not for anti-clotting drugs, not for cancer medications, not for statins.

The Journal article opines that, “The new Plavix studies may give a boost to personalized medicine as a cost-saving measure under President-elect Barack Obama. As an Illinois senator, he introduced a bill in Congress encouraging genomic research and personalized medicine that would "target the delivery of health care." Insurance companies might be able to limit prescriptions for Plavix based on patients' genetic makeup, as they do now with some cancer drugs.”

First of all, news articles shouldn't opine.  Secondly, personalized medicine is not about denying care.  It’s about providing the right care.  The four rights (right medicine at the right time to the right patient in the right dose).  And as far as “cost-savings” are concerned, not providing Plavix to some subset of patients (and particularly one as potentially large as 30%) doesn’t mean these patients don’t need treatment – it means they need alternate treatment, newer therapy, therapy that may cost more than Plavix does today – and considerably more once it goes off-patent.

And as far as former Senator Obama’s “Genomics and Personalized Medicine Act,” goes – I look forward to hearing about its passage during his first State of the Union address.

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Good Golly! Miss QALY?

12/30/2008 02:51 PM |

Earlier we commented on the future path of Britain’s National Health Service as spelled out in the “Darzi Report.”  (“Do you deny it, Mr. Darzi”)
 
One of Lord Darzi's recommendations is that NICE work faster so that the fine and timely work of the MHRA (the FDA’s sister agency in the United Kingdom) isn’t wasted.

According to NICE Chairman Sir Michael Rawlings, "Our ambition is to make sure guidance is available within three to six months.” He said this could be achieved by increasing the number of advisory committees and starting the evaluation process a year before a drug company expects to obtain a license. (Not a bad idea for similar action by CMS right here at home.)

That’s good news.  What’s better news is that Sir Michael seems to be almost, kind of, sort of ready to reconsider NICE’s inflexible devotion to the Holy QALY.

According to the NICE chairman, "People attach a special importance to extending the lives of [those with] mortal illnesses, even for a few months, and we appreciate these extra weeks and months can be very special.”

Further, "We are proposing to provide our advisory bodies with supplementary advice ... which will have the effect of extending the threshold range of what we would normally regard as cost-effective."

Good golly!  Miss QALY?

However, "We are not proposing to extend this to all conditions. Frankly, it would cost the NHS hundreds of millions of pounds."

Well, heaven forbid that the NHS should provide the best care when adequate care is available.  That’s cost-based versus patient-centric care.  That’s NICE.

In other words, when Sir Michael’s political masters feel the heat – NICE sees the light.  This is a case (one not unknown in American politics) of the squeaky wheel getting the oil.  And now that British citizens with “mortal illnesses” will finally be treated like human beings, it’s only a matter of time until every other segment of the British population figures out that where their best chances for best treatment lies – in public activism.

Is this any way to run an airline?

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